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The Effect of Physiotherapy on Dysfunctional Breathing in Children and Adolescents With and Without Asthma

Primary Purpose

Dysfunctional Breathing, Asthma in Children, Asthma

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Physiotherapy
standard care
Sponsored by
Kolding Sygehus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysfunctional Breathing focused on measuring Dysfunctional breathing, Asthma in children, Asthma in adolescents, Physiotherapy

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Asthma group:

  • Asthma diagnosed by lung function tests and/or typical symptoms.
  • Treatment with inhaled corticosteroids in minimum 3 months.
  • ACQ5 >= 1.5.
  • NQ >= 23.

NonAsthma group

  • Asthma denied after lung function tests ( exercise challenge or mannitol challenge)
  • NQ >= 23.

Exclusion Criteria:

  • Other significant cardiopulmonary or muscoluskeletal conditions.
  • Complex functional conditions involving other organ systems.
  • patients who already had the physotherapeutical intervention before study start.

Sites / Locations

  • Signe VahlkvistRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

+ asthma + intervention

+ asthma - intervention

- asthma + intervention

- asthma - intervention

Arm Description

35 participants with asthma aged 10-17 years, randomized to physiotherapy. The intervention consists of 4 instruction lessons spread over 6 weeks. The participants are instructed in a daily ten-minute-program of breathing exercizes.

35 participants with asthma aged 10-17 years, randomized to standard care. Participants are getting advice about dysfunctional breathing by a physician or nurse in the outpatient clinic.

35 participants without asthma aged 10-17 years, randomized to physiotherapy. The intervention consists of 4 instruction lessons spread over 6 weeks. The participants are instructed in a daily ten-minute-program of breathing exercizes.

35 participants without asthma, which are randomized to standard care. Participants are getting advise about dysfunctional breathing by a physician or nurse in the outpatient clinic.

Outcomes

Primary Outcome Measures

Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 months.
ACQ5 contains 5 questions regarding asthma symptoms. Each question is scored between 0-6 points, where 0 represents very good asthma control and 6 represents poor asthma control. Total ACQ score is calculates as an average of points. ACQ5 is taken by participants with asthma, at visits in the outpatient clinic.
Change from baseline in Pediatric Quality of Life Inventory ( PedsQl) at 6 months
PedsQl consists of 23 questions in 4 segments ( physical functioning, emotions, social interaction, and school activities). Each question is scored from 0 (best) to 4 (worst). The PedsQl questionnairre exists in formats for young children ( not used here), children aged 8-12 years and Teenagers aged 13-18 years. Children and adolescents are answering the age relevant questionnairre at visits in the out patient clinic. The PedsQl score is transformed to a 0-100 scale as follows: 0 =100, 1=75, 2=50, 3=25, 4=0. Health related Quality of life is calculated as a mean of scores. Psychosocial Health summary score is calculated as a mean of scores in the emotional, social and school functioning scales. Physical Health summary score is calculated as physical functioning scale score mean.

Secondary Outcome Measures

Change from baseline in Nijmegen Questionnaire ( NQ)
NQ consists of 16 questions regarding dysfunctional breathing. Each question is scored between 0-4 points, where 0 is best and 4 is worst.
Change from baseline in Brompton breathing Pattern Assesment Tool ( BBPAT)
BBPAT is a breathing scoring equipment where an observer is scoring the quality of breathing from seven parameters including respiratory rate, respiratory movements, in and expiratory sounds etc. Each parameter is scored from 0 ( best) to 2 ( worst). Total score is calculated between 0-14 point
Number of contacts to the hospital during one year from baseline
Number of total contacts includes planned visits, extra visits and hospitalisations
Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 weeks and one year. Change from 6 months in ACQ at 12 months.
ACQ5 contains 5 questions regarding asthma symptoms. Each question is scored between 0-6 points, where 0 represents very good asthma control and 6 represents poor asthma control. Total ACQ score is calculates as an average of points. ACQ5 is taken by participants with asthma in the outpatient clinic at baseline and after 6 weeks, 6 months and 12 months.
Change from baseline in Pediatric Quality of Life Inventory ( PedsQl) at at 6 weeks and one year. Change from 6 months in PedsQl at 12 months.
PedsQl consists of 23 questions in 4 segments ( physical functioning, emotions, social interaction, and school activities). Each question is scored from 0 (best) to 4 (worst). The PedsQl questionnairre exists in formats for young children ( not used here), children aged 10-13 years and Teenagers aged 13-18 years. Children and adolescents are answering the age relevant questionnairre at visits in the out patient clinic. The PedsQl score is transformed to a 0-100 scale as follows. 0 =100, 1=75, 2=50, 3=25, 4=0. Health related Quality of life is calculated as mean of scores. Psychosocial Health summary score is calculated as mean of scores in the emotional, social and school functioning scales. Physical Health summary score is calculated physical functioning scale score mean.
The reported use of rescue Beta2 agonist in puffs per week
The reported use of short acting beta 2 agonist in puffs per week the last week.

Full Information

First Posted
January 21, 2021
Last Updated
March 9, 2023
Sponsor
Kolding Sygehus
Collaborators
Odense Patient Data Explorative Network
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1. Study Identification

Unique Protocol Identification Number
NCT04728191
Brief Title
The Effect of Physiotherapy on Dysfunctional Breathing in Children and Adolescents With and Without Asthma
Official Title
The Effect of Physiotherapy on Dysfunctional Breathing in Children and Adolescents With and Without Asthma.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kolding Sygehus
Collaborators
Odense Patient Data Explorative Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to investigate the effect of physiotherapeutical instructions on dysfunctional breathing in children and adolescents with or without asthma. Children and adolescents with dysfunctional breathing, are invited to participate in the intervention study. Participants are stratified by asthma diagnose status and randomized to physiotherapy or standard care. Participants are followed a year after the intervention, to compare the development in asthma control ( if asthma) and quality of life.
Detailed Description
The purpose of the study is to investigate the effect of physiotherapeutical instructions on dysfunctional breathing in children and adolescents with or without asthma. All children and adolescents aged 10-17 years, followed in our outpatient clinic with the diagnose of asthma are invited to fulfill the Nijmegen Questionnaire (NQ) and the Asthma Control Questionnaire (ACQ5) Children and adolescents where asthma was investigated and ruled out are invited to fulfill the NQ. Data from the electronic patient journal are used as descriptives. Participants with dysfunctional breathing (NQ >= 23) are invited to participate in the intervention study. Participants are stratified by asthma diagnose status and randomized to physiotherapy or standard care. Participants are followed a year after the intervention, to compare the development in asthma control measured by ACQ5 (if asthma) and quality of life measured by PedsQL. The effect of physiotherapy is analyzed separately for participants with and without asthma. In addition, primary outcomes are analyzed in a regression model with asthma status, age and sex as explanatory variables.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysfunctional Breathing, Asthma in Children, Asthma
Keywords
Dysfunctional breathing, Asthma in children, Asthma in adolescents, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
+ asthma + intervention
Arm Type
Experimental
Arm Description
35 participants with asthma aged 10-17 years, randomized to physiotherapy. The intervention consists of 4 instruction lessons spread over 6 weeks. The participants are instructed in a daily ten-minute-program of breathing exercizes.
Arm Title
+ asthma - intervention
Arm Type
Active Comparator
Arm Description
35 participants with asthma aged 10-17 years, randomized to standard care. Participants are getting advice about dysfunctional breathing by a physician or nurse in the outpatient clinic.
Arm Title
- asthma + intervention
Arm Type
Experimental
Arm Description
35 participants without asthma aged 10-17 years, randomized to physiotherapy. The intervention consists of 4 instruction lessons spread over 6 weeks. The participants are instructed in a daily ten-minute-program of breathing exercizes.
Arm Title
- asthma - intervention
Arm Type
Active Comparator
Arm Description
35 participants without asthma, which are randomized to standard care. Participants are getting advise about dysfunctional breathing by a physician or nurse in the outpatient clinic.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
physiotherapeutical instructions and training as described.
Intervention Type
Other
Intervention Name(s)
standard care
Intervention Description
Standard care as described.
Primary Outcome Measure Information:
Title
Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 months.
Description
ACQ5 contains 5 questions regarding asthma symptoms. Each question is scored between 0-6 points, where 0 represents very good asthma control and 6 represents poor asthma control. Total ACQ score is calculates as an average of points. ACQ5 is taken by participants with asthma, at visits in the outpatient clinic.
Time Frame
ACQ is taken at baseline and 6 months after intervention as primary outcome.
Title
Change from baseline in Pediatric Quality of Life Inventory ( PedsQl) at 6 months
Description
PedsQl consists of 23 questions in 4 segments ( physical functioning, emotions, social interaction, and school activities). Each question is scored from 0 (best) to 4 (worst). The PedsQl questionnairre exists in formats for young children ( not used here), children aged 8-12 years and Teenagers aged 13-18 years. Children and adolescents are answering the age relevant questionnairre at visits in the out patient clinic. The PedsQl score is transformed to a 0-100 scale as follows: 0 =100, 1=75, 2=50, 3=25, 4=0. Health related Quality of life is calculated as a mean of scores. Psychosocial Health summary score is calculated as a mean of scores in the emotional, social and school functioning scales. Physical Health summary score is calculated as physical functioning scale score mean.
Time Frame
PedsQL is taken at baseline and 6 months after intervention as primary outcome.
Secondary Outcome Measure Information:
Title
Change from baseline in Nijmegen Questionnaire ( NQ)
Description
NQ consists of 16 questions regarding dysfunctional breathing. Each question is scored between 0-4 points, where 0 is best and 4 is worst.
Time Frame
NQ is taken at baseline and 6 weeks, 6 months and 12 months after intervention.
Title
Change from baseline in Brompton breathing Pattern Assesment Tool ( BBPAT)
Description
BBPAT is a breathing scoring equipment where an observer is scoring the quality of breathing from seven parameters including respiratory rate, respiratory movements, in and expiratory sounds etc. Each parameter is scored from 0 ( best) to 2 ( worst). Total score is calculated between 0-14 point
Time Frame
BBPAT is taken at baseline and 6 weeks, 6 months and 12 months after intervention.
Title
Number of contacts to the hospital during one year from baseline
Description
Number of total contacts includes planned visits, extra visits and hospitalisations
Time Frame
from baseline to 12 months after intervention.
Title
Change from baseline in Asthma Control Questionnaire ( ACQ5) at 6 weeks and one year. Change from 6 months in ACQ at 12 months.
Description
ACQ5 contains 5 questions regarding asthma symptoms. Each question is scored between 0-6 points, where 0 represents very good asthma control and 6 represents poor asthma control. Total ACQ score is calculates as an average of points. ACQ5 is taken by participants with asthma in the outpatient clinic at baseline and after 6 weeks, 6 months and 12 months.
Time Frame
ACQ5 is taken at 6 weeks and 12 months after intervention as secondary outcomes.
Title
Change from baseline in Pediatric Quality of Life Inventory ( PedsQl) at at 6 weeks and one year. Change from 6 months in PedsQl at 12 months.
Description
PedsQl consists of 23 questions in 4 segments ( physical functioning, emotions, social interaction, and school activities). Each question is scored from 0 (best) to 4 (worst). The PedsQl questionnairre exists in formats for young children ( not used here), children aged 10-13 years and Teenagers aged 13-18 years. Children and adolescents are answering the age relevant questionnairre at visits in the out patient clinic. The PedsQl score is transformed to a 0-100 scale as follows. 0 =100, 1=75, 2=50, 3=25, 4=0. Health related Quality of life is calculated as mean of scores. Psychosocial Health summary score is calculated as mean of scores in the emotional, social and school functioning scales. Physical Health summary score is calculated physical functioning scale score mean.
Time Frame
PedsQl is taken at 6 weeks and 12 months after intervention as secondary outcomes.
Title
The reported use of rescue Beta2 agonist in puffs per week
Description
The reported use of short acting beta 2 agonist in puffs per week the last week.
Time Frame
at baseline and 6 weeks, 6 months and 12 months after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Asthma group: Asthma diagnosed by lung function tests and/or typical symptoms. Treatment with inhaled corticosteroids in minimum 3 months. ACQ5 >= 1.5. NQ >= 23. NonAsthma group Asthma denied after lung function tests ( exercise challenge or mannitol challenge) NQ >= 23. Exclusion Criteria: Other significant cardiopulmonary or muscoluskeletal conditions. Complex functional conditions involving other organ systems. patients who already had the physotherapeutical intervention before study start.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Signe Vahlkvist, PhD
Phone
+45 20 23 14 30
Email
Signe.Vahlkvist@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Louise Jürgensen, MD
Email
Anne.louise.jürgensen@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Signe Vahlkvist, PhD
Organizational Affiliation
Kolding Sygehus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Signe Vahlkvist
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Signe Vahlkvist, PhD
Email
Signe.Vahlkvist@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Louise Jürgensen, MD
Email
Anne.louise.Jürgensen@rsyd.dk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie published results, after deidentification.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal. Proposals should be directed to Open@rsyd.dk.
IPD Sharing URL
http://open.rsyd.dk

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The Effect of Physiotherapy on Dysfunctional Breathing in Children and Adolescents With and Without Asthma

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